Analyzing changes in oral microbiome during dental implant placement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to investigate the changes in the oral microbiome that occur when patients transition from having some teeth to being fully edentulous, as well as after the placement of dental implants. It focuses on individuals with severe periodontitis and evaluates how different implant materials and surfaces may influence microbial colonization. The study will also assess the variability of these changes to inform future longitudinal studies. By understanding these dynamics, the research seeks to improve outcomes for patients undergoing dental implant procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. At least 21 years of age
2. Diagnosis of Stage III or IV periodontitis based on full mouth probing and full mouth x-rays
3. Planned for full mouth extraction and replacement by dental implants.
4. Rehabilitation with Implant supported restorations either maxilla and/ or mandible.
5. At least 2 implants available for examination.
6. No bone augmentation required.

Exclusion Criteria:

1. Conditions requiring chronic routine prophylactic use of antibiotics.
2. Conditions requiring prolonged use of steroids.
3. History of leukocyte dysfunction and deficiencies
4. Bleeding disorders
5. History of neoplastic disease requiring use of radiation or chemotherapy
6. Metabolic bone disorders
7. Uncontrolled endocrine disorder
8. Use of any investigational drug or device within the 30 day period prior to implant surgery.

10\. Alcoholism or drug abuse 11. Patient infected with HIV 12. Condition or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability.

Local Exclusion Criteria

1. Local inflammation
2. Mucosal disease such as erosive lichen planus
3. History of local irradiation therapy
4. Osseous lesion.
5. Active infection with suppuration or fistula track.
6. Persistent intraoral infection different than periodontitis

Where it's running

• Case Western Reserve University Department of Periodontics
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Gian Pietro Schincaglia, DDS,PhD — Case Western Reserve University
• Study coordinator: Gian Pietro Schincaglia, DDS,PhD
• Email: gxs486@case.edu
• Phone: 216-368-4412

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.